BPA Biomonitoring Study in Cashiers - Full Text View

Purpose

We intend to conduct a pilot study designed to measure BPA levels before and after occupational exposure to thermal paper used in cash registers. We will recruit cashiers from a local commercial store that is currently still using BPA-laden thermal paper and plans to switch to BPA-free paper in the near future. The study uses a within-subject comparison design, using serum and urine samples to determine whether BPA is detectable in the study population at sufficient levels to measure differences in paired samples. Two phases of sample collection are proposed: Phase I - collecting paired samples on two separate occasions before the implementation of BPA-free thermal paper use in cash registers; and Phase II - collecting paired samples on two separate occasions after the implementation of this change in thermal paper.

Condition	Phase
Bisphenol A	Phase 1

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	BPA Biomonitoring Study in Cashiers

Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment:	0
Study Start Date:	January 2011
Estimated Study Completion Date:	December 2012

Detailed Description:

We intend to conduct a pilot study designed to measure BPA levels before and after occupational exposure to thermal paper used in cash registers. We will recruit cashiers from a local commercial store that is currently still using BPA-laden thermal paper and plans to switch to BPA-free paper in the near future. The study uses a within-subject comparison design, using serum and urine samples to determine whether BPA is detectable in the study population at sufficient levels to measure differences in paired samples. Two phases of sample collection are proposed: Phase I - collecting paired samples on two separate occasions before the implementation of BPA-free thermal paper use in cash registers; and Phase II - collecting paired samples on two separate occasions after the implementation of this change in thermal paper.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:
Male or female 18 years of age or older at the time of enrollment
Employed as a cashier at the site location
Anticipate continued employment at this business for the duration of both phases of the study
Able to understand and provide written informed consent to participate in the study
Have a minimum of 24 hours off from work before providing pre-shift samples
Participants may be healthy or have preexisting conditions.

Field Site Inclusion Criteria:

Have a minimum of 20 employed cashiers
Use BPA-laden thermal paper and is planning to switch to BPA-free thermal paper
Have a private area that the study nurse can use for enrollment and collection of biological samples
Willing to collaborate with study team to conduct study on-site

EXCLUSION CRITERIA:

-There are no additional exclusion criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287169

Sponsors and Collaborators

National Institute of Environmental Health Sciences (NIEHS)

Investigators

Principal Investigator:

Darryl C Zeldin, M.D.

National Institute of Environmental Health Sciences (NIEHS)

More Information

Publications:

Biedermann S, Tschudin P, Grob K. Transfer of bisphenol A from thermal printer paper to the skin. Anal Bioanal Chem. 2010 Sep;398(1):571-6. Epub 2010 Jul 11.

Calafat AM, Ye X, Wong LY, Reidy JA, Needham LL. Exposure of the U.S. population to bisphenol A and 4-tertiary-octylphenol: 2003-2004. Environ Health Perspect. 2008 Jan;116(1):39-44.

Kang JH, Kondo F, Katayama Y. Human exposure to bisphenol A. Toxicology. 2006 Sep 21;226(2-3):79-89. Epub 2006 Jun 16. Review.

ClinicalTrials.gov Identifier:	NCT01287169 History of Changes
Other Study ID Numbers:	999911074, 11-E-N074
Study First Received:	January 29, 2011
Last Updated:	May 3, 2013
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Bisphenol A

ClinicalTrials.gov processed this record on May 21, 2013